Description:

• Serves as study lead and primary (internal and external) contact for clinical studies

• Leads and manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, US and Ex US regulatory guidelines and operate within established timelines

• Responsible for managing the study budget and reviewing forecasts, accruals and actual spend

• Manages outsourced clinical operations functions, which may include Clinical Research Organizations, contracted investigational supply, data management, biostatistics, etc.

• Generates and presents frequent study status updates and reports to internal team

• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.

• Oversees and tracks patient recruitment and pro-actively identifies ways to prevent recruitment delays

• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones

Additional Skills & Qualifications:

Global experience required- preferably EU

Indication/ Therapeutic experience: preferably rare disease or immunology

Phase II experience- this is a Phase IIa study

preferably small biotech/pharma experience

open to overseeing people down the road (2 CTAs)

5-8 years of CTM experience

Bachelor's degree

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.